The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children

Measurement of Docosahexaenoic Acid Levels in Pre-school Children Clinical Trial

Official title:

The Effects of Feeding Different Levels of Docosahexaenoic Acid to Pre-School Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01897948
• Other study ID #: 6022
• Status: Terminated
• Phase: N/A
• First received: July 3, 2013
• Last updated: April 4, 2014
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This clinical trial will measure Docosahexaenic Acid (DHA) levels in the blood and evaluate the relation to cognitive outcomes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 3 Years

Eligibility

Inclusion Criteria:

• Child is 3 years of age ± 90 days

• Weight for length is within 10th to 90th percentile as plotted on WHO growth charts

• Parent/caregiver reports that child consumes at least 6 oz of cow milk or cow milk-based beverages on a daily basis

• Parent is willing to exclude sources of DHA from child's diet during the study

• Parent agrees not to give vitamins to child during the study

• English is the primary language in the home

• Signed Informed Consent and Protected Health Information

Exclusion Criteria:

• Gestational age at birth = 36 weeks

• History of neuro/psychiatric conditions

• History of underlying metabolic or chronic disease

• Child is ill, has used antihistamines or diagnosed with an infection at time of cognitive testing

• History of suspected or known cow milk protein intolerance

• Child's diet contains sources of supplemental DHA more than one time per week

• Child is from a multiple birth and the sibling(s) are living in the same household

• Child is enrolled in another interventional clinical research study

• Use of antihistamines within 12 hours of cognitive testing

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Measurement of Docosahexaenoic Acid Levels in Pre-school Children

Intervention

Other:
• Milk-based beverage without DHA

• Milk-based beverage with DHA at mid level

• Milk-based beverage with DHA at high level

Locations

Country	Name	City	State
United States	Universty of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	John Colombo, PhD, The University of Kansas, University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red Blood Cell phospholipid weight percent of Docosahexaenoic Acid		6 months	No
Primary	Cognitive Measures - Executive Function, Language Development, and Behavior Assessment		6 months	No
Secondary	Fatty Acid Desaturase (FADS) genotypes		Once	No
Secondary	Plasma Vitamin D levels		6 months	No
Secondary	Iron levels in the blood		6 months	No
Secondary	Blood Pressure		6 months	No
Secondary	Heart Rate		6 months	No
Secondary	Height and Weight		6 months	No
Secondary	Recall of dietary intake at each study visit		6 months	No
Secondary	Parental Product Assessment Questionnaire completed at Study Visit 2		once	No
Secondary	Medically-confirmed adverse events collected throughout the study period		6 months	Yes